In accordance to a survey due to the Movement of IVC Filter, Fracture Linked to Hundreds of Injuries & 27 Deaths. The device was introduced in 1979, and its use increased continuously through the years. By 2012, doctors inserted approximately 259,000 filters in patients. Report on IVC filters and the recent controversy that has arisen over the devices states that several numbers of lawsuits have been filed in court related to the failures of the devices. NBC News reports states that a major device manufacturer, CF Bard, knew about dangers with one type of IVC filter but failed to share this information with the public, unnecessarily placing patients at risk.
A number of patients have reported that the filter has migrated to another part of the body or has actually fractured, thus sending pieces to travel through the bloodstream. As the pieces move through the body there is a potential danger that they could puncture veins or the pieces could become embedded into vital organs or intestines. Unfortunately for some patients, they have been told by their doctors that the pieces cannot be removed since they have migrated and settled in parts of the body considered as too “high risk” for surgical removal. This presents long-term issues for the patient. Many lawsuits have been filed by patients alleging that they have been placed in this dangerous situation.
An Inferior Vena Cava (IVC) filter is a medical device that is used to prevent blood clots from traveling to the lungs. IVC filters are implanted into the Vena Cava, the largest vein in the body, which transports “used” blood from the tissues and organs to the heart, where it is pumped to the lungs to be oxygenated and re-used. IVC filters are used in patients with certain clotting disorders like deep vein thrombosis (DVT) who cannot take anticoagulant medication. They are intended to “catch” blood clots before they reach the lungs and become a pulmonary embolism which can be fatal. There are two types of IVC filters, permanent and optional or retrievable. Some filters are permanent, and some are retrievable or temporary. Doctors remove retrievable filters in a similar way that they implant them. Healthcare providers inject contrast or X-ray dye around the device to make sure it is safe to proceed with the removal. A catheter-like snare goes into the vein and grabs the hook located at the end of the filter. The filter is then covered by a sheath and pulled out of the vein. While doctors use these devices to help save lives, they also have serious side effects including vein and organ perforation, migration and breakage. Broken pieces of filters can travel through the body, damaging organs. Some doctors and patients also accuse IVC manufacturers of hiding these risks.
Recent studies have identified IVC filters to have dangerous and potentially life threatening side effects. If an IVC device -fails, it can cause a number of serious adverse events. From 2005 to 2010, the Food & Drug Administration received at least 921 reports of adverse events associated with IVC. As per a survey 328 cases involving device migration to the heart or pulmonary artery causing fluid accumulation, heart arrhythmia or death, 146 cases reported about involving remobilization (blockage in the artery) after detachment of IVC filter components, 70 cases are about involving filter perforation (damage to artery walls and/or organs) and 56 cases involving filter fracture. Approximately 4% casesassociates to death.There are several complications that have been associated with IVC filters. Some of the more serious side-effects include:
- Internal Bleeding (Hemorrhagic Pericardial Effusion or Other Hemorrhage)
- Cardiac Tamponade or Pericardial Tamponade
- Punctured Veins or Punctured Vena Cava
- Fracture of the IVC Filter
- Perforation, Puncture or Serious Damage to the Heart, Lungs or Vena Cava
- Internal Bleeding
- Cardiac or Pericardial Tamponade
- Ventricle Tachycardia
- Lower Limb DVT
- Hematoma or Nerve Injury at the Puncture Site
The FDA issued a second alert regarding the importance of retrieving IVC filters, and recommended that the devices be removed between 29 and 54 days after implantation. Patients who believe their vena cava filters may have fractured should contact their doctor immediately. A computerized tomography (CT) scan or other test will be used to determine whether the device has failed.